Law D, Zhang Z
Centre for Formulation Engineering, Department of Chemical Engineering, School of Engineering, University of Birmingham, Edgbaston, Birmingham, UK.
Drug Dev Ind Pharm. 2007 May;33(5):495-503. doi: 10.1080/03639040601050247.
The aim of the work is to develop a new formulation in order to stabilize a nutraceutical enzyme Nattokinase (NKCP) in powders and to control its release rate when it passes through the gastrointestinal tract of human. NKCP powders were first compacted into a tablet, which was then coated with a mixture of an enteric material Eudragit L100-55 (EL100-55) and Hydroxypropylcellulose (HPC) by direct compression. The activity of the enzyme was determined using amidolytic assay and its release rates in artificial gastric juice and an intestinal fluid were quantified using bicinchoninic acid assay. Results have shown that the activity of NKCP was pressure independent and the coated tablets protected NKCP from being denatured in the gastric juice, and realized its controlled release to the intestine based on in vitro experiments.
这项工作的目的是开发一种新配方，以稳定粉末状营养酶纳豆激酶（NKCP），并控制其通过人体胃肠道时的释放速率。首先将NKCP粉末压制成片剂，然后通过直接压片用肠溶材料丙烯酸树脂L100-55（EL100-55）和羟丙基纤维素（HPC）的混合物进行包衣。使用酰胺分解测定法测定酶的活性，并使用二辛可宁酸测定法定量其在人工胃液和肠液中的释放速率。结果表明，NKCP的活性与压力无关，包衣片剂可保护NKCP在胃液中不被变性，并根据体外实验实现其在肠道中的控释。
